A Pilot Study Evaluating 18F-L-Thymidine (FLT) PET Imaging in Children With Gliomas
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 10/21/2012 |
| Start Date: | April 2010 |
| Contact: | Robyn Bent, R.N. |
| Email: | rbent@mail.nih.gov |
| Phone: | (301) 496-4256 |
Background:
- Children with brain tumors often have magnetic resonance imaging (MRI) scans to see if
the tumor has responded to therapy or to see if the tumor has grown. Sometimes, it is
difficult to tell if the scan is abnormal because of tumor size or shape, swelling,
scar tissue, or dead tissue. Because brain tumor biopsies require surgery, researchers
are looking for more noninvasive ways of evaluating brain tumors.
- Positron emission tomography (PET) scans use a radioactive sugar known as 18F-FDG to
try to determine if a tumor is active or not. Active tumors generally take up more
sugar than the surrounding tissue, but because normal brain tissue uses the same sugar
as brain tumors, it is then difficult to tell if tumor tissue is taking up sugar or
not. A different radioactive agent, 18F-FLT, is now being studied in some adults with
different kinds of tumors. Researchers are interested in determining whether it is
possible to use this agent as a marker of tumor activity in children.
Objectives:
- To determine the safety and effectiveness of 18F-FLT for pediatric glioma scans.
- To compare the results of 18F-FLT studies with studies using the radioactive agents
18F-FDG and 1H-MRSI.
Eligibility:
- Children less than 18 years of age who are having radiation therapy to treat malignant
gliomas.
Design:
- Participants will have scanning tests before radiation therapy, 1 to 3 weeks after
radiation therapy, and if researchers suspect that the tumor is growing.
- This study will involve three separate imaging tests (1H-MRSI, 18F-FDG PET, and 18F-FLT
PET).
- Proton spectroscopy (1H-MRSI) is a procedure that is similar to MRI and is performed in
the same scanner as an MRI. Because this scan is long (2-3 hours), most children will
receive medications from an anesthesiologist so that they can sleep through the
procedure.
- Within 2 weeks of the 1H-MRSI scan, participants will have the PET scans with both the
standard contrast agent (18F-FDG) and the experimental agent (18F-FLT). These scans
will last approximately 1 hour each.
BACKGROUND:
- A limitation of current investigational therapy for patients with brain tumors is
assessment of response.
- (18)F-FDG PET is commonly used to assess tumor metabolism. However, normal brain uses
glucose as an energy source, resulting in increased background FDG uptake, which
confounds results and makes it difficult to distinguish normal from neoplastic
activity.
- Newer imaging techniques that noninvasively assess metabolic and physiologic
characteristics of brain tumor tissue are being developed to identify biomarkers of
clinical efficacy in trials of new molecularly targeted agents.
- (18)F-fluorothymidine (FLT) is a PET radiopharmaceutical that is taken up by
proliferating cells and may therefore serve as a surrogate marker of early response or
lack of response to treatment.
- This study will prospectively evaluate (18)F-FLT in children undergoing radiation
therapy for gliomas.
OBJECTIVES:
Primary objectives:
- Determine the feasibility of (18)F-FLT PET imaging in pediatric patients with malignant
gliomas
- Determine the ability of (18)F-FLT PET imaging to detect treatment changes in pediatric
patients with malignant gliomas undergoing radiation therapy
Secondary objectives:
- Determine the safety and toxicity profile of PET imaging using (18)F-FLT in pediatric
patients with malignant gliomas
- To correlate changes in (18)F-FLT PET before and after radiation with outcome (12 month
PFS)
- To compare the performance of (18)F-FLT-PET to that of MR perfusion, proton magnetic
resonance spectroscopy (1H-MRSI) and (18)F-FDG PET in prediction of tumor response,
time to progression and overall survival time.
ELIGIBILITY:
- Children less than 18 years of age with malignant gliomas for whom radiation therapy is
prescribed.
- Adequate organ function defined as:
- Hepatic: SGOT, SGPT less than 5 times the ULN; total and direct bilirubin less
than or equal to 2 times the ULN
- Renal: Serum creatinine must be within the upper limit of normal values
- Fasting serum glucose less than 150 mg/dL
- Negative serum or urine pregnancy test in females of childbearing potential
DESIGN:
-Patients will undergo MRI (with 1H-MRSI and perfusion), (18)F-FLT PET and (18)F-FDG PET
within 2 weeks of each other at the following time points: pre-radiation therapy, 1-3 weeks
post-radiation therapy, and at the time of suspected progression.
- INCLUSION CRITERIA:
- Age: 1 year to less than 18 years of age
- Diagnosis: Patients must have a histologic diagnosis of a malignant glioma for which
radiation therapy is prescribed. Patients with DIPG or optic pathway gliomas are
exempt from this requirement and do not require a histologic diagnosis. All patients
must have evaluable (not necessarily measurable) disease.
- Weight less than or equal to 70 kg (to limit radioisotope exposure to maximum adult
dose)
- All patients or their legal guardians must sign a document of informed consent
indicating their awareness of the investigational nature and risks of this study.
- Organ Function: Patients must have adequate organ function defined as:
Hepatic: SGOT/AST, SGPT/ALT less than 5 times the ULN, Total bilirubin less than or equal
to 2 times the ULN
Renal: Serum creatinine within the upper limit of normal values for age
Serum Glucose: less than 150 mg/dL
- Female patients of childbearing potential must have a negative serum or urine
pregnancy test
- Patients must be able to undergo both the FLT and FDG PET without the use of general
anesthesia.
EXCLUSION CRITERIA:
- Patients unable to undergo MR imaging for any reason (including but not limited to
the presence of a metallic implant that is not MRI compatible)
- Pregnant women are excluded because of known harmful effects of radiation on the
fetus and the unknown effects of strong magnetic fields and Gadolinium contrast
agents on the fetus.
- Any patient with a history of severe reaction (requiring medication) to Gd-DTPA, FDG
or FLT.
- Any patient with permanent dental hardware, which, in the judgment of the Principal
Investigator, would interfere with obtaining spectroscopy in the area of the tumor.
- Any patient who has begun an investigational agent within 48 hours prior to receiving
(18)F-FLT.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-4000
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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